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Mitomics Launches Test for Detecting Prostate Cancer from Negative Biopsies


By Ben Butkus

This article has been updated from a previous version to correct the name of the test.

Canadian molecular diagnostics firm Mitomics today launched its first product, the Prostate Core Mitomic Test for determining the presence of malignant cells in normal-appearing tissue in biopsy samples.

The laboratory-developed, quantitative PCR-based test is now available to physicians in the US through the company's CLIA lab in Aurora, Colo.

Known as Genesis Genomics until last year, Mitomics has built its pipeline of molecular diagnostic products around the core idea that large-scale deletions in mitochondrial DNA can indicate cellular changes indicative of the development of prostate cancer; and that these changes can be detected in otherwise normal-appearing tissue that may have surrounded a malignancy, a concept known as the cancerization field effect.

Mitomics' technology detects these changes, or lack thereof, from formalin-fixed, paraffin-embedded biopsy samples, making the test appropriate for physicians to administer to patients who had a negative biopsy but who still appear to display common symptoms associated with the disease.

"It basically tells the urologist [whether] they should go in and follow this patient more closely, or that they might not need to follow him quite as closely" following a negative biopsy result, Jennifer Creed, chief development officer for Mitomics, told PCR Insider.

According to Mitomics, it is estimated that more than 1 million prostate biopsies are performed annually in the US, and although approximately 70 percent of all initial biopsies are negative, anywhere from 25 percent to 60 percent of these are positive on second or subsequent biopsy.

Catching these false negatives without another biopsy is crucial as prostate cancer is treatable if detected early but often fatal if it is not. Mitomics said that its test has demonstrated a sensitivity of 84 percent and has been shown to accurately rule out prostate cancer with a negative predictive value of 91 percent.

Mitomics launched PCMT on a qPCR-based detection platform, "because of its reliability and its fairly standardized processes," Creed said, although she added that the test is "pretty platform-neutral."

In addition, PCMT is actually well-suited for FFPE tissues, unlike many molecular tests where the DNA is degraded by the archiving process.

"Because mitochondrial has a 100- to 1,000-fold copy number greater than the nuclear archive of information, it appears to be a better target for these biomarkers, so when you start to look at these biopsy samples …. you can get results from almost any patient," CSO Ryan Parr told PCR Insider.

As a laboratory-developed test, PCMT is available only through Mitomics' CLIA lab. The company is considering seeking regulatory approval from the US Food and Drug Administration, but in order to do so, "additional studies will be needed to satisfy FDA requirements, and that's a decision we will make corporately," Creed said.

Further down the road, Mitomics is eyeing additional tests for prostate cancer, including the Prostate Positive Mitomic Test to determine prostate cancer aggressiveness; the Prostate Mitomic Test, a urine-based test for predicting the disease following an elevated PSA level; and the Breast Mitomic Test for early detection of breast cancer from nipple aspirate fluid.

In all of these tests, Mitomics is "almost ubiquitously capitalizing on the field effect and the high copy number of mitochondrial mutations," Creed said. "While it may not be the same markers, it would be the same processes we are detecting."

Mitomics said that in anticipation of this week's launch, it has been building its US sales team by hiring employees to support PCMT marketing in the initial target markets of Baltimore, Boston, Cleveland, Philadelphia, and Chicago.

Have topics you'd like to see covered in PCR Insider? Contact the editor at bbutkus [at] genomeweb [.] com